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Acupuncture and Related Therapies Used As Add-On Or www.nature.com/scientificreports OPEN Acupuncture and related therapies used as add-on or alternative to prokinetics for functional Received: 6 January 2017 Accepted: 1 August 2017 dyspepsia: overview of systematic Published: xx xx xxxx reviews and network meta-analysis Robin S. T. Ho1, Vincent C. H. Chung 1,2,3, Charlene H. L. Wong2, Justin C. Y. Wu2, Samuel Y. S. Wong1,2 & Irene X. Y. Wu2,3 Prokinetics for functional dyspepsia (FD) have relatively higher number needed to treat values. Acupuncture and related therapies could be used as add-on or alternative. An overview of systematic reviews (SRs) and network meta-analyses (NMA) were performed to evaluate the comparative efectiveness of diferent acupuncture and related therapies. We conducted a comprehensive literature search for SRs of randomized controlled trials (RCTs) in eight international and Chinese databases. Data from eligible RCTs were extracted for random efect pairwise meta-analyses. NMA was used to explore the most efective treatment among acupuncture and related therapies used alone or as add-on to prokinetics, compared to prokinetics alone. From fve SRs, 22 RCTs assessing various acupuncture and related therapies were included. No serious adverse events were reported. Two pairwise meta- analyses showed manual acupuncture has marginally stronger efect in alleviating global FD symptoms, compared to domperidone or itopride. Results from NMA showed combination of manual acupuncture and clebopride has the highest probability in alleviating patient reported global FD symptom. Combination of manual acupuncture and clebopride has the highest probability of being the most efective treatment for FD symptoms. Patients who are contraindicated for prokinetics may use manual acupuncture or moxibustion as alternative. Future confrmatory comparative efectiveness trials should compare clebopride add-on manual acupuncture with domperidone add-on manual acupuncture and moxibustion. Rationale. Functional dyspepsia (FD) is defned as pain or discomfort of the upper digestive tract in the absence of an organic cause that readily explains them1. One or more of the following symptoms are usually observed: postprandial fullness, early satiation, epigastric pain or burning2. FD is classifed into two subtypes, postprandial distress syndrome (PDS, characterized by postprandial fullness and early satiation) and epigastric pain syndrome (EPS, characterized by epigastric pain and epigastric burning)2. Te prevalence of FD ranged from 12 to 15% in the general population3. FD signifcantly reduces quality of life of patients, hence contributes to signifcant disease burden, treatment cost and loss of productivity4. Current guidelines and expert consensus5–9 recommend the use of prokinetics as one of the routine treatments for FD. Efectiveness of prokinetics is however unsatisfactory, with a number needed to treat (NNT) of 1610. In addition, potential side efects of prokinetics have raised concern on their longer term use. For instance, exist- ing studies suggest association between prokinetics use and increased risk of extra-pyramidal reactions, cardiac arrhythmic side efects including sudden cardiac death and drug-induced neurological disorders11–14. Tere is a need for addressing the efectiveness gap of those who are experiencing limited benefts from prokinetics, or those who are contraindicated to them. 1Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Shatin, Hong Kong. 2Hong Kong Institute of Integrative Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong. 3Cochrane Hong Kong, The Chinese University of Hong Kong, Shatin, Hong Kong. Correspondence and requests for materials should be addressed to V.C.H.C. (email: [email protected]) SCIENTIFIC REPORTS | 7: 10320 | DOI:10.1038/s41598-017-09856-0 1 www.nature.com/scientificreports/ Needle insertion into acupuncture points, followed by manual manipulation. Te function of Manual acupuncture needling is believed to be to promote Qi (the vital energy) in the meridians in order to produce its therapeutic efect. A method in which a moxa herb is burned above the skin or on the acupuncture points. It Moxibustion can be used as a cone stick, loose herb, or applied at the end of the acupuncture needles. Te purpose of moxibustion is to apply heat to the acupuncture points to alleviate symptoms. One type of modern acupuncture technique used with manual acupuncture, where needle is Electroacupuncture attached to a trace pulse current afer it is inserted to the selected acupoint for the purpose of producing synthetic efect of electric and needling stimulation. Table 1. Defnitions of modalities of acupuncture and related therapies in this overview of systematic review. Figure 1. Flowchart of literature selection on systematic reviews on acupuncture and related therapies for functional dyspepsia. In traditional Chinese medicine, acupuncture and related therapies have been used for treating functional gastrointestinal disorders (FGIDs) including FD15, 16. Existing evidence has shown the efcacy of acupuncture beyond sham control. In a Cochrane review of three trials, meta-analyses indicated that manual acupuncture was superior to sham acupuncture, for improving quality of life measured by SF-36 and Nepean Dyspepsia Life Quality Index17. Another meta-analysis performed by Kim and colleagues has shown that manual acupuncture was superior to sham acupuncture in FD symptoms reduction18. In a meta-analysis performed by Zhou and colleagues19, they have also shown that both manual acupuncture and electroacupuncture were superior to sham acupuncture, in the improvement of Nepean Dyspepsia Index. When acupuncture and related therapies were compared with prokinetics, evidence from existing systematic reviews (SRs) is inconsistent. One SR showed similar efectiveness in FD symptoms reduction between manual acupuncture or electroacupuncture versus domperidone, as well as electroacupuncture versus itopride, in three separate trials17. However, meta-analyses from three other SRs showed that acupuncture and related therapies were more efective than prokinetics for FD symptoms reduction18–20. Tese heterogeneous results make it difcult to draw conclusions on the efectiveness of acupuncture and related therapies on FD, used as an add-on or alternative to prokinetics. Tere is a need to perform an overview of SRs to clarify such uncertainty, as well as to assess the comparative efectiveness among diferent types of acu- puncture and related therapies. SCIENTIFIC REPORTS | 7: 10320 | DOI:10.1038/s41598-017-09856-0 2 www.nature.com/scientificreports/ Figure 2. Flowchart for randomized controlled trials selection for acupuncture and related therapies for functional dyspepsia. Objectives. We conducted an overview of SRs to critically appraise and synthesize all clinical evidence on the comparative efectiveness of diferent acupuncture and related therapies on the treatment of FD, using a network meta-analysis (NMA) approach21. Methods Search methods for identifcation of studies. Four electronic international (Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Efect, MEDLINE, and EMBASE) and four Chinese electronic databases (Wan Fang Digital Journals, China National Knowledge Infrastructure, Taiwan Periodical literature databases and Chinese Biomedical Database) were searched for potential SRs from their inception till November 2015. Validated, sensitivity maximized search flters for systematic reviews were applied in MEDLINE and EMBASE searches22, 23. Te searches were limited to human studies and no language restriction was applied. Te search strategies are presented in Appendix 1. Types of studies. To be included in this overview, SRs must include meta-analysis results, and satisfy the participants, interventions, controls and outcomes of interest criteria described below. SRs which only reported data narratively were excluded. Types of participants. Patients diagnosed with FD according to Rome criteria, or other criteria stated by the authors were considered. Tere was no restriction on the versions of Rome criteria used. Types of intervention. In this overview of SR, we only include three specifc modalities: manual acu- puncture, electroacupuncture, and moxibustion, as defned in Table 1 24. Accordingly, in this overview of SR we defned “acupuncture and related therapies” as single or combined use of manual acupuncture, moxibustion and electroacupuncture. Accordingly, acupuncture and related therapies including the single or combined use of manual acupuncture, moxibustion, electroacupuncture were considered eligible for this overview. Prokinetics can be used as an add-on or alternative to these interventions. Prokinetics which are available in the market were eligible in the comparison group except cisapride. We chose to exclude cisapride as it has been removed from market due to serious adverse events25. Trials which evaluate combined therapy of proton pump inhibitors (PPIs) and prokinetics was excluded, as substantial side efects of their combined use have been shown in recent meta-analyses26. Combined therapy of H2 histamine receptor antagonist (H2RA) and prokinetics was also excluded, as H2RA has shown to be associated with an increased risk of pneumonia by a meta-analysis27, vitamin B12 defciency by a case-control study28 and impaired cognitive function among elderlies by a cohort study29. Outcome measures. Trials results reported from each meta-analysis should include at least one of the fol-
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